NDC 0781-3182

fomepizole

Fomepizole

fomepizole is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Sandoz Inc.. The primary component is Fomepizole.

Product ID0781-3182_a306cd11-9acf-45f1-91ec-9fef2b08fdb1
NDC0781-3182
Product TypeHuman Prescription Drug
Proprietary Namefomepizole
Generic NameFomepizole
Dosage FormInjection, Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2008-03-06
Marketing CategoryANDA / ANDA
Application NumberANDA078537
Labeler NameSandoz Inc.
Substance NameFOMEPIZOLE
Active Ingredient Strength1 g/mL
Pharm ClassesAntidote [EPC]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 0781-3182-84

4 CARTON in 1 CARTON (0781-3182-84) > 1 VIAL in 1 CARTON (0781-3182-73) > 1.5 mL in 1 VIAL
Marketing Start Date2008-03-06
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0781-3182-73 [00781318273]

fomepizole INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA078537
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2008-03-06

NDC 0781-3182-84 [00781318284]

fomepizole INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA078537
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2008-03-06
Inactivation Date2019-10-21

Drug Details

Active Ingredients

IngredientStrength
FOMEPIZOLE1 g/mL

OpenFDA Data

SPL SET ID:a306cd11-9acf-45f1-91ec-9fef2b08fdb1
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 310414
  • UPC Code
  • 0307813182733
  • Pharmacological Class

    • Antidote [EPC]

    NDC Crossover Matching brand name "fomepizole" or generic name "Fomepizole"

    NDCBrand NameGeneric Name
    0517-0710fomepizolefomepizole
    0781-3182fomepizolefomepizole
    67457-211FomepizoleFomepizole
    68475-510FomepizoleFomepizole
    70710-1478FomepizoleFomepizole
    46129-200Antizolfomepizole

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